AuthorisedTherapeutic use (Phase IV)Interventional

NT-proBNP Selected PreventiOn of cardiac eveNts in a populaTion of dIabetic patients without A history of Cardiac disease; a prospective randomized trial

This research study is for people in the UK with type 2 diabetes who haven't had any heart problems in the past. It's investigating if certain heart medications, like those used to treat high blood pressure or heart failure, can help prevent future heart-related issues, such as heart attacks or needing hospital care for your heart. The study uses a blood test called NT-proBNP, which gives doctors information about your heart health, to help decide on the best treatment. Essentially, it wants to see if using these medicines, guided by this blood test, can keep your heart healthier for longer if you have diabetes but no known heart disease.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Medical University Of Vienna

Enrolment target

448

Start

14 Feb 2025

Diabetes mellitus Type 2

What is this study about?

This study is particularly important for people in the UK who have type 2 diabetes but haven't experienced any heart problems before, like a heart attack or heart failure. We know that over time, diabetes can increase your risk of developing heart disease. This research aims to find out if certain common medications, which are already used to help manage blood pressure or heart conditions, can actually prevent these heart problems from happening in the first place.

The study also includes a specific blood test called NT-proBNP. This test measures a substance in your blood that can tell doctors a lot about how well your heart is working. Researchers want to see if using this blood test to guide which medications are given, and how they are used, can lead to better heart health outcomes for people with type 2 diabetes.

Ultimately, this study is about finding the best ways to protect the hearts of people with type 2 diabetes. By understanding if these medications, guided by blood tests, can stop heart problems before they start, doctors can offer more effective preventative care, potentially improving quality of life and helping people live longer, healthier lives.

Key takeaways

This study is for adults with type 2 diabetes who haven't had heart problems.
It investigates if common heart medications can prevent future heart issues.
A blood test (NT-proBNP) guides the treatment approach.
Participation involves regular check-ups and monitoring.
It aims to improve preventative care for people with diabetes.

Who may be eligible?

To join this study, you would generally need to be an adult, aged 18 or older. Both men and women can take part.

A key part of being eligible is that you must have type 2 diabetes. However, it's really important that you haven't been diagnosed with any heart problems in the past, such as heart attacks, heart failure, or other significant heart diseases.

There might be other specific health checks and tests that the study team would need to do to make sure the study is right and safe for you. Your doctor would be able to give you all the detailed information.

Quick self-check

I am 18 years old or older.
I have been diagnosed with type 2 diabetes.
I have NOT had a heart attack, heart failure, or other known heart disease.
I am willing to attend regular clinic appointments.
I am interested in potentially taking study medication to protect my heart.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular visits to a clinic over a period of time. During these visits, you might have check-ups, blood tests (including the NT-proBNP test), and other assessments to monitor your heart health and overall well-being. You would be given study medication, which are existing common heart drugs, and the study team would closely monitor how you're doing with them. The total length of your participation would depend on the study design, but research studies often involve follow-up over several years to see how treatments work in the long term. All appointments and procedures directly related to the study would be arranged and explained to you by the study team.

Potential risks and benefits

Potential benefits of participating could include closer monitoring of your heart health and diabetes, and potentially receiving a medication that helps protect your heart even before problems arise. However, as with any medication, there can be potential risks or side effects, which the study team would explain in full before you agree to take part. These medications are already widely used, so their side effects are well-known. You would be carefully monitored for any issues. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without explaining why, and this would not affect your usual medical care.

Locations (2)

—
Spain
—
Austria

Common questions

What kind of medications are being tested?

The study is looking at several existing medications commonly used for blood pressure or heart conditions, like those in the 'pril' or 'sartan' families of drugs. They are not new, experimental drugs.

What is NT-proBNP?

NT-proBNP is a substance found in your blood that gives doctors information about your heart. Higher levels can sometimes mean your heart is working harder than it should.

Will I definitely receive a study medication?

Participants in clinical trials are usually split into groups. Some receive the study medication, others might receive a different treatment, or sometimes a placebo (a dummy pill). The study team will explain how this works.

How long will the study last for me?

The total duration of your involvement in the study will be clearly explained by the researchers, as it can vary. It often involves follow-up over several years to see the long-term effects of treatments.

Will my regular doctor still be involved?

Yes, your regular doctor will usually be kept informed about your participation in the study and your general health. The study team works alongside your usual care providers.